Studieoverzicht - 2013-07 mastectomie

Number 2013-07 mastectomie
Nickname 2013-07 mastectomie
Status Closed Date: 01-10-2017
Inclusion closed
Other study number(s)
Participating parties/groups
Full title The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch multicentre cohort study.
Phase and type Non-randomized Phase III
Age ≥18
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 878
Actual accrual 4 Date: 01-02-2018
Estimated study completion date 31-05-2017
CCMO approval Not applicable Date: 29-04-2014 Nr: NL44110.031.13
EudraCT nr. Not applicable
Trial Register NCT02112682
METC approval Yes Date: 29-04-2014 METC: Nederlands Kanker Instituut Nr: M14CAT
Amendments Yes Date:
KWF-CKS approval Yes Date: 13-06-2013 Nr: KWF UM 2013-5920
News item
Website , voor patienten:
Sponsor MUMC+
Principal Investigator(s) M.L. Smidt, J.H.W. de Wilt
Study manager M.L.G. Vane (studycoordinator Maastricht UMC+)
R. de Peuter (trialconsulent IKNL)
Central datamanagement and randomization IKNL Clinical Trial Centre
Tel: +31 (0)88 234 6500
Fax: +31 (0)88 234 6011
Local datamanagement IKNL
Funding Logo KWF en Pink Ribbon samen.jpg


A prospective non-inferiority multicentre cohort study.

Patient group:

Clinically T1-2N0 invasive breast cancer patients undergoing a mastectomy with a minimum of 1 micro- and a maximum of 3 macrometastatic axillary sentinel lymph nodes (pN1mi / pN1).

Intervention - Eligible patients will be treated according following treatment groups:
Arm A - control arm: mastectomy with completion axillary treatment
Arm B - study arm: mastectomy without completion axillary treatment

- Stratification:
Patients will be stratified by: age (≤50, 50≤75, >75), oestrogen receptor status (positive vs. negative), HER2neu status (amplified vs. not-amplified), lymph node metastasis (micro vs. macrometastasis), clinical tumour size prior to any treatment (<3cm vs. ≥3cm), grading (grade I-II vs. III - according to
modified Bloom-Richardson grading system), neoadjuvant systemic therapy and participating center.


Primary objective:

The primary objective of this study is to investigate whether omitting completion axillary treatment is not inferior to the current axillary treatment regimens in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.

Secondary objectives:

Secondary objectives of this study are to investigate whether omitting completion axillary treatment is not inferior to the current axillary treatment regimes in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of distant-disease free survival, overall survival rate, the local recurrence rate and the occurrence of contralateral breast cancer. Other secondary objectives are the administration of postoperative radiotherapy and the influence of omitting completion axillary treatment on the number of
delayed axillary lymph node dissections, the axillary morbidity rate and quality of life.


Primary endpoint:

Regional recurrence rate.

Secondary endpoints:

Regional recurrence free survival, number of delayed axillary lymph node dissections, distant-disease free survival, overall survival, local recurrence rate, other-regional recurrence rate, contralateral breast cancer rate, percentage difference in the administration of postoperative radiotherapy, axillary morbidity rate, quality of life.

Main eligibility criteria:

Inclusion criteria:

1. Female
2. Aged 18 years or older
3. Pathologically confirmed invasive unilateral breast carcinoma
4. A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
5. Will be or is treated with mastectomy
6. Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
7. SLN procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
8. pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
9. Written informed consent

Furthermore, neoadjuvant systemic therapy and primary and secondary breast reconstructions are also allowed.

Exclusion criteria:

1. Clinically node positive pre-operative
2. Sentinel lymph nodes only containing isolated tumour cells (<0.2mm)
3. Solitary parasternal sentinel lymph node metastasis (pN1b)
4. Bilateral breast cancer
5.Irradical resection of primary tumour at time of registration (applicable in case the mastectomy is      performed before registration)

6. Evidence of metastatic disease
7. History of invasive breast cancer
8. Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
9. Pregnant or nursing
10. Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before registration
11. Unable or unwilling to give informed consent

Documents (public):

BOOG 2013-07 Protocol synopsis versie 1.2


Film; "Hoe bespreek ik de BOOG 2013-07 studie met mijn patiënt?" 

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